Taiwan FDA registration c163e50a333cb4bfb888678e7a02e2b8
“Biohit” PepsinogenⅠ
TW: “百得” 胃蛋白酶原Ⅰ酵素免疫檢測試劑
Taiwan·Risk Class 2·MD·BIOHIT OYJ·Registered Dec 02, 2015 – Dec 02, 2025ExpiredRegistration details
- Analysis ID
- c163e50a333cb4bfb888678e7a02e2b8
- License Form
- Ministry of Health Medical Device Import No. 027927
- Customs Code
- DHA05602792704
Company information
- Manufacturer
- BIOHIT OYJ
- Manufacturer Country
- Finland
- Authorized Representative
- YOULUM BIOTECHNOLOGY CO., LTD.
Product details
- Intended Use
- This product uses enzyme-linked immunosorbent assay (ELISA) technology to quantitatively detect PGI in human plasma or serum for in vitro diagnosis.
- Product Type (Level 1)
- C Immunology and microbiology devices
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Dec 02, 2015
- Expiry Date
- Dec 02, 2025
About this record
Access comprehensive regulatory information for “Biohit” PepsinogenⅠ in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number c163e50a333cb4bfb888678e7a02e2b8 and manufactured by BIOHIT OYJ. The authorized representative in Taiwan is YOULUM BIOTECHNOLOGY CO., LTD..
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